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Generated: September 22, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 077512

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NDA 077512 describes ESCITALOPRAM OXALATE, which is a drug marketed by Invagen Pharms, Macleods Pharms Ltd, Sti Pharma Llc, Amneal Pharms, Hetero Labs Ltd Iii, Taro, Aurobindo Pharma Ltd, Prinston Inc, Zydus Pharms Usa Inc, Torrent Pharms Ltd, Mylan Pharms Inc, Teva Pharms Usa, Hikma Pharms, Antrim Pharms Llc, Lupin Ltd, Silarx Pharms Inc, Apotex Inc, Jubilant Generics, and Accord Hlthcare, and is included in twenty-three NDAs. It is available from fifty-four suppliers. Additional details are available on the ESCITALOPRAM OXALATE profile page.

The generic ingredient in ESCITALOPRAM OXALATE is escitalopram oxalate. There are twenty-five drug master file entries for this compound. Fifty-nine suppliers are listed for this compound. Additional details are available on the escitalopram oxalate profile page.

Summary for NDA: 077512

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:0
Therapeutic Class:Antidepressants
Anxiolytics

Pharmacology for NDA: 077512

Mechanism of ActionSerotonin Uptake Inhibitors

Suppliers and Packaging for NDA: 077512

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ESCITALOPRAM OXALATE
escitalopram oxalate
TABLET;ORAL 077512 ANDA STI Pharma LLC 54879-009 54879-009-01 100 TABLET, FILM COATED in 1 BOTTLE (54879-009-01)
ESCITALOPRAM OXALATE
escitalopram oxalate
TABLET;ORAL 077512 ANDA STI Pharma LLC 54879-010 54879-010-01 100 TABLET, FILM COATED in 1 BOTTLE (54879-010-01)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 5MG BASE
Approval Date:Sep 12, 2012TE:ABRLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 10MG BASE
Approval Date:Sep 12, 2012TE:ABRLD:No

Summary for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 20MG BASE
Approval Date:Sep 12, 2012TE:ABRLD:No


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Serving 500+ biopharmaceutical companies globally:

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